Clinical Outcome After Implantation of Two Different Multifocal Toric IOLs: Liberty (677MTY) and PanOptix®

Comparison of Clinical Outcome After Implantation With Two Different Multifocal Toric Intraocular Lens: Liberty Trifocal 677MTY (Medicontur) and PanOptix® Multifocal Toric (Alcon) Lens, With Respect to Rotational Stability, Visual Outcomes, Patients' Satisfaction, YAG Capsulotomy Rate

This study is to compare the rotational stability, visual outcome and patient satisfaction after implantation with either Liberty 677MTY, a multifocal diffractive-refractive IOL based on EPS technology manufactured by Medicontur Ltd. (Zsámbék, Hungary) or the multifocal toric IOL PanOptix®, manufactured by Alcon.

Study Overview

• Status: Completed
• Conditions: Cataract

Detailed Description

According to numerous estimations, 15% to 29% of patients with cataract have more than 1.5 diopters of refractive astigmatism. Corneal astigmatism can be reduced with a variety of surgical techniques including selective positioning of the phacoemulsification incision, corneal relaxing incision, implantation of toric IOLs, photorefractive keratectomy and there are first results of implantation of short arc-length intrastromal corneal ring segments for correcting astigmatism and myopia . The use of toric IOLs to reduce visually significant keratometric astigmatism offers a rational, more predictable and stable method of refractive correction. Implanting a toric intraocular lens offers the possibility of correcting not only spherical equivalent of refraction, but also astigmatism. The success of a toric IOL can be judged not only by its ability to reduce refractive astigmatism immediately postoperatively, but also by its ability to maintain a stable position in the capsular bag in the longer term. Even a small rotational deviation of the toric IOL from its intended axis can result in large reduction of the astigmatic correction.

The purpose of this study is to evaluate and compare the visual outcomes, spectacle independency, visual disturbances (glares, halos), neuronal adaptation and patient satisfaction after implantation of either the Liberty 677MTY (a multifocal diffractive apodized toric intraocular lens- diffractive-refractive IOL based on EPS technology manufactured by Medicontur Ltd. Zsámbék, Hungary) or the multifocal toric PanOptix® IOL, manufactured by Alcon.

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• Hungary
  • Veszprém, Hungary, 8200
    • Retinaszervíz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients with cataract

Description

Inclusion Criteria:

The enrolled subjects will be the patients with cataract and pre-existing regular corneal astigmatism between 1.0 to 6.0 dpt.

Exclusion Criteria:

• astigmatism less than 1 dpt
• irregular astigmatism
• diabetic retinopathy
• iris neovascularisation
• serious intraoperative complications
• congenital eye abnormality
• glaucoma
• pseudoexfoliation syndrom
• amblyopia
• uveitis
• long-term anti-inflammatory treatment
• AMD (advanced AMD)
• retinal detachment
• prior ocular surgery in personal medical history
• corneal diseases
• severe retinal diseases (dystrophy, degeneration)
• severe myopia (if required IOL power is lower than 10 D)
• inadequate visualization of the fundus on preoperative examination
• patients deemed by the clinical investigator because of any systemic disease.
• eye trauma in medical history intraoperative exclusions:
• tear in capsulorhexis
• zonular dehiscence
• posterior capsular rupture
• vitreous loss and other unexpected surgical complication

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Liberty; The group implanted with Liberty 677MTY
PanOptix; The group implanted with PanOptix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rotational stability	Rotational stability will be measured using slit lamp images of the implanted lens	Day 1
Rotational stability	Rotational stability will be measured using slit lamp images of the implanted lens	3 months
Rotational stability	Rotational stability will be measured using slit lamp images of the implanted lens	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contrast sensitivity	Contrast sensitivity in photopic and mesopic light conditions with or without glare will be assessed one year postoperatively using CSV-1000	1 year
Patient satisfaction	Patient satisfaction will be measures with the VFQ-14 questionnaire	3 months
Patient satisfaction	Patient satisfaction will be measures with the VFQ-14 questionnaire	1 year
Visual outcome (UDVA, CDVA, UIVA, DCIVA, UNVA, DCNVA)	Monocular and binocular visual aquity will be measured at far, intermediate and near by standard ETDRS chart.	1 month
Visual outcome (UDVA, CDVA, UIVA, DCIVA, UNVA, DCNVA)	Monocular and binocular visual aquity will be measured at far, intermediate and near by standard ETDRS chart	3 months
Visual outcome (UDVA, CDVA, UIVA, DCIVA, UNVA, DCNVA)	Monocular and binocular visual aquity will be measured at far, intermediate and near distances by standard ETDRS chart	1 year
Contrast sensitivity defocus curve	Contrast sensitivity defocus curve will be assessed using the Multifocal Lense Analyser iPAD application.	3 months
Contrast sensitivity defocus curve	Contrast sensitivity defocus curve will be assessed using the Multifocal Lense Analyser iPAD application.	1 year
Multifocality (Visual Acuity Defocus Curve)	The multifocality of the lens will be evaluated also by monocular and binocular visual acuity defocus curves (VADC) using the multifocal lens analyser iPAD application	3 months
Multifocality (Visual Acuity Defocus Curve)	The multifocality of the lens will be evaluated also by monocular and binocular visual acuity defocus curves using the multifocal lens analyser iPAD application.	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety outcome - Intraoperative complications	Intraoperative complications of cataract surgery; Posterior capsular or zonular rupture; Vitreous loss/anterior vitrectomy or aspiration; Iris/ciliary body injury; Loss of nuclear material into vitreous; Suprachoroidal haemorrhage; Retrobulbar haemorrhage	Day1 postoperatively
Safety outcome - Postoperative complications	Postoperative complications of cataract surgery; Cystoid macular oedema; Iris abnormalities; Corneal oedema; Wound leak or rupture; IOL dislocation, removal, or exchange; Inflammation (Endophthalmitis, anterior chamber cells, anterior chamber flare, hypopyon); Retinal tear, break, or detachment; Persistent iritis; Elevated intraocular pressure; Pupillary block; Cornea status	Month1 postoperatively
Safety outcome - Complications of IOL implantation	Complications of IOL implantation; Posterior capsular opacification (PCO); Opacification, IOL discoloration	Month 12 postoperatively

Collaborators and Investigators

• Sponsor: Medicontur Medical Engineering Ltd
• Investigators: Principal Investigator: József F Győry, MD, Retinaszerviz Kft. (8200 Veszprém, Vörösmarty tér 6, Hungary)

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2020
• Primary Completion (Actual): May 10, 2024
• Study Completion (Actual): May 10, 2024

Study Registration Dates

• First Submitted: December 17, 2020
• First Submitted That Met QC Criteria: May 31, 2023
• First Posted (Actual): June 8, 2023

Study Record Updates

• Last Update Posted (Actual): August 30, 2024
• Last Update Submitted That Met QC Criteria: August 28, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 677MTY _PanOptix_HU_2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No